Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183729

Purpose

This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or cardiopulmonary condition.

Condition	Intervention	Phase
Depression	Drug: Memantine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Memantine for Enhancement of Rehabilitation Efficacy and Prevention of Major Depressive Disorder in Older Adults

Resource links provided by NLM:

MedlinePlus related topics: Depression Rehabilitation

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Depressive symptoms [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]
Incidence of major depressive disorder [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]
Functional recovery [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measures of helplessness [ Time Frame: Measured at Week 12 and Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Memantine	Drug: Memantine Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
2: Placebo Comparator Placebo	Drug: Placebo Placebo distribution is planned to mimic the active drug.

Detailed Description:

Depression is a serious medical illness that is often difficult to diagnose and treat. It occurs in people of all ages, but is often overlooked in older adults. Depression frequently co-occurs with other serious illnesses, and may be mistaken by both patients and health care givers as a normal consequence of the illness. However, these misconceptions toward depression contribute to the underdiagnosis and undertreatment of depressive disorders in older people. In turn, depression may hinder a patient's recovery from an illness. This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or a cardiopulmonary condition.

This double-blind study will last for 12 months. Participants will be randomly assigned to receive either placebo or memantine, which is a drug that is often used to treat Alzheimer's disease. Both memantine and placebo will be administered to participants for 12 weeks. All participants will be followed for an additional 40 weeks. Outcome measurements will include participants' depressive symptoms, motivation, and learned helplessness. In addition, medication side effects, functional outcome, and incidence of major depressive disorder will be measured. All measurements will be taken at Week 12 and Month 12.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Admission to a skilled nursing facility for rehabilitation within 3 months of recent disabling medical event (e.g., hip fracture)
Medically stable (e.g., no active seizures, delirium, unstable pulse/blood pressure)

Exclusion Criteria:

Aphasia or cognitive impairments sufficiently severe to prevent valid assessment (e.g., a score of less than 22 on the Mini Mental State Examination)
Current major depressive episode
History of or current psychosis or mania
Current substance or alcohol abuse or dependence (within 3 months of study entry)
Current use of memantine
Sensitivity or contraindication to memantine
End-stage kidney, liver, heart, or lung disease
Recent hemorrhagic stroke
A FIM score of greater than 70 (on a 91 point scale)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183729

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Eric J. Lenze, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	University of Pittsburgh ( Ellen Whyte, MD )
Study ID Numbers:	K23 MH64196-02, DATR AK-TNGP2
Study First Received:	September 14, 2005
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00183729 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Major depressive disorder
Rehabilitating
Elderly
Apathy

Additional relevant MeSH terms:

Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Depressive Disorder, Major
Depressive Disorder

Pharmacologic Actions
Behavioral Symptoms
Mental Disorders
Therapeutic Uses
Mood Disorders
Memantine
Dopamine Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on November 05, 2009